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Safety in Lactation: Drugs for the relief of soft-tissue inflammation and topical pain relief

28 October 2020Topical formulations of non-steroidal anti-inflammatories (NSAIDS) and capsaicin produce low systemic levels in the mother. Although there is no direct evidence, subsequent milk levels are…

Suggestions for Therapeutic Drug Monitoring in Adults in Primary Care

29 September 2020This document is intended to support local discussions on how to monitor commonly prescribed high risk medicines in primary care.    The monitoring parameters cited…

Safety in Lactation: Non-steroidal anti-inflammatory drugs

23 September 2020There is very limited information on the use of NSAIDs during breastfeeding; ibuprofen and diclofenac are the preferred choices due to their extensive safe use…

Can breastfeeding mothers take ibuprofen?

28 May 2020Ibuprofen is one of the painkillers of choice whilst breastfeeding. This Medicines Q&A evaluates the available evidence for the safety of ibuprofen in breastfeeding mothers,…

Do NSAIDs increase the risk of severe skin reactions in children with chickenpox?

1 October 2019This Q&A evaluates the limited published evidence investigating an association between Non-steroidal anti-inflammatory drugs (NSAIDs) and severe skin reactions in children with chickenpox.
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Medicine Compliance Aid Stability

genericWockhardt UK Ltd

Wockhardt UK Ltd
generic
Tablets 400mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from moisture
Protect from light. Protect from moisture
12 August 2015

Brufen RetardAbbott Healthcare Products Ltd

Abbott Healthcare Products Ltd
Brufen Retard
Tablets 800mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from light
12 August 2015

BrufenAbbott Healthcare Products Ltd

Abbott Healthcare Products Ltd
Brufen
Tablets 200mg, 400mg, 600mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from light
12 August 2015

Lactation Safety Information

Yes
Extensive experience of safe use in breastfeeding
Limited published evidence of safety
No adverse effects reported in breastfed infants
Negligible amounts in breast milk
24 September 2020
Q&A

Topical

Topical
Yes
Negligible milk levels anticipated as systemic absorption from topical formulations is low
Follow normal precautions for topical medicines (see summary)
24 September 2020

New Medicines

Acute moderate pain - short-term treatment (IV infusion)

Information

New formulation
Dr Reddy's Laboratories
Not known

Development and Regulatory status

Launched
Launched
None
November 2020
Dec 20Dr Reddy ibuprofen 400mg/100ml infusion bags are available in the UK, possibly since November. Price £186 for 20 bags. [4].
Sep 19Ibuprofen is licensed for use in adults for the short-term symptomatic treatment of acute moderate pain, when administration by intravenous route is clinically justified when other routes of administration are not possible [1].
Sep 19Licensed in the UK. Company plans to launch in 2020 [1,2].

Category

Intravenous infusion formulation of the NSAID, ibuprofen
Of people who undergo surgery, almost 60% experience severe pain in the post‑operative period [3].
Acute moderate pain - short-term treatment (IV infusion)
Intravenous infusion

Trial or other data

Nov 20The product is presented as a ready to use solution containing 4mg/ml ibuprofen in 100ml (400mg) or 150ml (600mg) bags for administration over 30 minutes as IV infusion. Indicated for short term treatment (max 3 days) when oral administration is inappropriate. Patients must switch to oral as soon as possible. Offers a potential alternative to IV ketorolac and diclofenac for acute pain with a potentially more favourable COX-1:COX-2 inhibition ratio vs ketorolac. May reduce opioid requirements [2].

Evidence based evaluations

Acute moderate pain and fever in adults - short-term treatment (IV infusion)

Information

New formulation
B Braun Medical
Not known

Development and Regulatory status

Licensed but not launched
Launched
Not known
May 21May 21: Braun advise that the product will launch in the next few weeks [5].
Apr 17Ibuprofen is licensed for use in adults for the short-term symptomatic treatment of acute moderate pain, and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified when other routes of administration are not possible [1].
Apr 17Date of first authorisation in the UK. Company plans to launch Q1 2020 [1,2].

Category

Intravenous infusion formulation of the NSAID, ibuprofen. Available as 400mg and 600mg infusions.
Of people who undergo surgery, almost 60% experience severe pain in the post‑operative period [4].
Acute moderate pain and fever in adults - short-term treatment (IV infusion)
Intravenous infusion

Trial or other data

Nov 20The product is ready to administer (over 30 minutes as IV infusion) so needs no manipulation at ward level, and is presented in the B Braun Ecoflac semi rigid container which collapses uniformly by itself with no need for added devices to aid venting. Offers a potential alternative to IV ketorolac and diclofenac for acute pain. Price to be confirmed. Likely to be lower cost per dose than Akis (diclofenac) IV but may require more frequent dosing [2,3].

Evidence based evaluations

Acute moderate pain and fever in children and adolescents weighing 20kg and over, and aged 6 years and over - short-term treatment (IV infusion)

Information

Licence extension / variation
B Braun Medical
Not Known

Development and Regulatory status

Licensed but not launched
None
None
May 21May 21: Braun advise that the product will launch in the next few weeks [3].
Jan 20Ibuprofen is licensed for use in adolescents and children from 20 kg bodyweight and 6 years of age and above for the short-term symptomatic treatment of acute moderate pain and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified, when other routes of administration are not possible [1].

Category

Intravenous infusion formulation of the NSAID, ibuprofen. Available as a 200mg infusion.
Of people who undergo surgery, almost 60% experience severe pain in the post‑operative period [2].
Acute moderate pain and fever in children and adolescents weighing 20kg and over, and aged 6 years and over - short-term treatment (IV infusion)
Intravenous infusion

Trial or other data

Nov 20The product is ready to administer (over 30 minutes as IV infusion) so needs no manipulation at ward level, and is presented in the B Braun Ecoflac semi rigid container which collapses uniformly by itself with no need for added devices to aid venting. Offers a potential alternative to IV ketorolac and diclofenac for acute pain. Price to be confirmed. Likely to be lower cost per dose than Akis (diclofenac) IV but may require more frequent dosing [2,3].

Evidence based evaluations